Clinical Study Unit (CSU) Local Innovation Lead is accountable for the delivery of digital / innovation strategy, performing innovative deliverable local optimization considering relative risk and impact, make periodic gap analysis of the strategy implementation and ensuring local CSU digital / innovation strategy aligns with the Global CSU digital / innovation strategy, and serving as a change agent, promoting and disseminating information related to innovation within the CSU.

• Coordinates clinical activities on local and international trials• Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for the assigned trials key responsibilities• Collaborates with the Medical Advisor to identify potential investigators• Organizes kick-off meeting with monitoring teams and vendors• Organizes training of monitoring teams and organizes investigators meetings• Prepares study budget and ensures optimization of costs through continuous budget review• Organizes the selection and validation of study vendors and overseens vendors activities• Prepares basic documents for initial submission process and to answer clarifications/requests from Ethic Committees and Health Authority• Ensures preparation and proper response to audit/inspection reports and implementation of recommendations• Oversees archiving process at study closureTherapeutic Experience: Hypercholesterolemia and cardiovascular disease, ImmunoInflammation (Giant Cell Arteritis), Oncology, Neurology (Multiple sclerosis)

On assignment to pharmaceutical company in the position of Clinical Project Leader- Coordinates clinical activities on local and international trials - Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for the assigned trials key responsibilities- Collaborates with the Medical Advisor to identify potential investigators- Organizes kick-off meeting with monitoring teams- Organizes training of monitoring teams and organizes investigators meetings- Prepares local study budget and ensures optimization of costs through continuous budget review- Organizes the selection and validation of study vendors and oversees vendors activities- Prepares basic documents for initial submission process and to answer clarifications/requests from Ethic Committees and Health Authority- Ensures preparation and proper response to audit/inspection reports and implementation of recommendations- Oversees archiving process at study closure

Support Clinical Operation Managers with overseeing the conduct of assigned clinical project to ensure the successful coordination of activities associated with the planning and execution of clinical trials within Italy. Act as the main contact for sites & global study team during the conduct of clinical trailsResponsibility:- Project Management of global and local studies- Ensure study meets milestones - Access site quality and performanceKey Activities:- Works with local study teams to coordinate EC/regulatory submission activities, meet operational milestones and manage day-by-day operations of study- Supports delivery of study-specific training to CRA- Review Monitoring Visit Reports and develops action plans for issues relating to quality, data flow and other risks- Communicates study progress and escalates issues to global team and other key stakeholders- Engages with local medical team to support priority studies- Support development of Monitoring Plans and review of Data Management PlansTherapeutic Area: General MedicineStudy Type: Phase III & IV

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP. Involvement, when required, in other areas of study management and staff training. Contribute to the review of systems and procedures, as appropriate.Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to company’s values which centre around a commitment to People, Clients and Performance.Independently and proactively coordinate the necessary activities required to set up and monitora study.Therapy area: oncology (NSCLC mainly, Brest cancer, Gastric cancer), hematology (multiple myeloma, anemia, lymphoma)Study type: phase II & III

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP. Involvement, when required, in other areas of study management and staff training. Contribute to the review of systems and procedures, as appropriate.Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to company’s values which centre around a commitment to People, Clients and Performance.Independently and proactively coordinate the necessary activities required to set up and monitora study.Therapy area: oncology (NSCLC mainly, Brest cancer), hematology (multiple myeloma, anemia, lymphoma)Study type: phase II & III

Responsibilities include identification, selection, initiation and close-out of appropriate investigational sites for clinical studies. monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs, applicable regulations and the principles of ICH-GCP.Involvement, when required, in other areas of study management and staff training and contribute to the review of system and procedures, as appropriate.Therapy area: oncology (NSCLC mainly, Brest cancer), hematology (multiple myeloma, anemia, lymphoma)Study type: phase II & III

- Set up and progress of a clinical trial/observational study within the allocated countries, ensuring compliance with quality standards and regulations in force, the forecasted timelines, milestones and budget- Leads the monitoring teams and guarantees all activities to start up, initiation, conduct and completion the clinical trials for the country sites- Coordinates as main contact the CRO in case of subcontracted studies, in particular manages the relation with the PM in order to verify the study conduction and solve deviations, manage the study budget allocated for the CRO activities and provide progress to the affiliate- Collaborates with Medical Affairs providing input to feasibility, study design, site selection, budget development and study progress- Performs on site visit (site selection, site initiation, monitoring and closure) and maintains contacts with Principal Investigator and site staff in order to manage each study phaseTherapy area: oncology (in particular prostate cancer), diabetes (type I and II), lysosomal storage disorders (Gaucher, Fabry, MPSI and Pompe)Study type: early access programs, phases III/IIIb and registries (both disease and product registries)

Support of Clinical Project Leader (CPL) in coordination and supervision of active treatment and epidemiological trials (National and International trials).Therapy area experience: diabetic, cardiovascular, orthopaedic and oncology area.

Società di Management Consulting e Information Technology in campo farmaceutico SAE evaluation and revision during the data migration from the old client’s database to the new one and working in Oracle platform.